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The OSTEOPATHIC Trial: The OSTEOPAThic Health Outcomes In Chronic Low Back Pain Trial

This study has been completed.
Sponsor:
Collaborators:
Osteopathic Heritage Foundations
Information provided by:
University of North Texas Health Science Center
ClinicalTrials.gov Identifier:
NCT00315120
First received: April 13, 2006
Last updated: May 9, 2011
Last verified: May 2011
  Purpose

The purpose of this study is to determine whether osteopathic manipulative treatment (a type of spinal manipulative therapy used by osteopathic physicians) and ultrasound physical therapy are effective in the treatment of chronic low back pain.


Condition Intervention Phase
Low Back Pain
Procedure: Active osteopathic manipulation and active ultrasound physical therapy
Procedure: Sham osteopathic manipulation and active ultrasound physical therapy
Procedure: Active osteopathic manipulation and sham ultrasound physical therapy
Procedure: Sham osteopathic manipulation and sham ultrasound physical therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Osteopathic Manipulative Treatment and Ultrasound Physical Therapy for Chronic Low Back Pain

Resource links provided by NLM:


Further study details as provided by University of North Texas Health Science Center:

Primary Outcome Measures:
  • Visual analogue scale score for pain [ Time Frame: 1, 2, 4, 8, 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Roland Morris Disability Questionnaire [ Time Frame: 4, 8, 12 weeks ] [ Designated as safety issue: No ]
  • Medical Outcomes Study SF-36 Health Survey [ Time Frame: 4, 8, 12 weeks ] [ Designated as safety issue: No ]
  • Work disability [ Time Frame: 4, 8, 12 weeks ] [ Designated as safety issue: No ]
  • Satisfaction with back care [ Time Frame: 4, 8, 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 488
Study Start Date: August 2006
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A
Active osteopathic manipulation and active ultrasound physical therapy
Procedure: Active osteopathic manipulation and active ultrasound physical therapy
Active osteopathic manipulation and active ultrasound physical therapy
B
Sham osteopathic manipulation and active ultrasound physical therapy
Procedure: Sham osteopathic manipulation and active ultrasound physical therapy
Sham osteopathic manipulation and active ultrasound physical therapy
C
Active osteopathic manipulation and sham ultrasound physical therapy
Procedure: Active osteopathic manipulation and sham ultrasound physical therapy
Active osteopathic manipulation and sham ultrasound physical therapy
D
Sham osteopathic manipulation and sham ultrasound physical therapy
Procedure: Sham osteopathic manipulation and sham ultrasound physical therapy
Sham osteopathic manipulation and sham ultrasound physical therapy

Detailed Description:

The purpose of this study is to determine whether osteopathic manipulative treatment (a type of spinal manipulative therapy used by osteopathic physicians) and ultrasound physical therapy are effective in the treatment of chronic low back pain.

  Eligibility

Ages Eligible for Study:   21 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must give a positive response to the question: "Have you had low back pain constantly or on most days for the last three months?"
  • Must identify the low back as the primary site of pain
  • Must agree to not receive any of the following outside of the study during the period of participation: osteopathic manipulative treatment, chiropractic adjustment (including "mobilization" or "manipulation"), physical therapy
  • Women must not be pregnant or plan to become pregnant during the period of study participation (a negative pregnancy test and willingness to maintain an acceptable method of contraception will be required)

Exclusion Criteria:

  • History of any of the following conditions which may be underlying causes of low back symptoms: cancer, spinal osteomyelitis, spinal fracture, herniated disc, ankylosing spondylitis, cauda equina syndrome
  • History of surgery involving the low back within the past year or planned low back surgery in the future
  • History of receiving Workers' Compensation benefits within the past three months
  • Involvement in current litigation relating to back problems
  • Current pregnancy or plan to become pregnant during the course of participation in the study
  • Any of the following that may limit a provider's choice of osteopathic manipulative treatment techniques or hamper compliance with the study protocol: angina or congestive heart failure symptoms that occur at rest or with minimal activity, history of a stroke or transient ischemic attack within the past year
  • Any of the following that may represent potential contraindications to receiving ultrasound physical therapy: implantation of a cardiac pacemaker, implantation of artificial joints or other biomedical devices, active bleeding or infection in the low back, pregnancy
  • Use of intravenous, intramuscular, or oral corticosteroids within the past month
  • History of osteopathic manipulative treatment, chiropractic adjustment, or physical therapy within the past three months or on more than three occasions during the past year
  • Practitioner or student of any of the following: osteopathic medicine (D.O.) allopathic medicine (M.D.), chiropractic (D.C.), physical therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315120

Locations
United States, Texas
The Osteopathic Research Center
Fort Worth, Texas, United States, 76107
Sponsors and Collaborators
University of North Texas Health Science Center
Osteopathic Heritage Foundations
Investigators
Principal Investigator: John C. Licciardone, DO, MS, MBA The Osteopathic Research Center, University of North Texas Health Science Center at Fort Worth
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John C. Licciardone, D.O., M.S., M.B.A., The Osteopathic Research Center
ClinicalTrials.gov Identifier: NCT00315120     History of Changes
Other Study ID Numbers: 06-02-20-1, NIH grant no.: K24 AT002422
Study First Received: April 13, 2006
Last Updated: May 9, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Texas Health Science Center:
Randomized controlled trial
Low back pain
Spinal manipulative therapy
Spinal manipulation
Osteopathic manipulation
Osteopathic medicine
Physical therapy modalities

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014